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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
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18-19 November, 2024
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CORPORATE CONTENT #SupplierSpotlight
NEWS #PharmaBuzz
16 Nov 2024
// PHARMABIZ
28 Oct 2024
// #N/A
24 Oct 2024
// PRESS RELEASE
18 Oct 2024
// PRESS RELEASE
10 Oct 2024
// INDPHARMAPOST
26 Sep 2024
// ECONOMICTIMES
Drugs in Development
Lead Product(s) : Fluoxetine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Pharma Subsidiary Receives USFDA Approval for 60 mg Fluoxetine Tablets
Details : Fluoxetine hydrochloride, is an antidepressant of the SSRIs class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, etc.
Brand Name : Fluoxetine HCl-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2024
Lead Product(s) : Theophylline
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Gets USFDA Nod for Theophylline Extended-Release Tablets
Details : Theophylline extended-release tablets formulation approved for the use in the treatment of asthma and chronic obstructive pulmonary disease.
Brand Name : Theo-Dur-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 07, 2024
Lead Product(s) : Sucralfate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL
Details : Carafate-generic (sucralfate) is a USFDA approved pepsin A inhibitor small molecule drug candidate, which is indicated for the treatment of active duodenal ulcer.
Brand Name : Carafate-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 23, 2024
Lead Product(s) : Sevelamer Hydrochloride
Therapeutic Area : Nephrology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Sevelamer Carbonate Tablets
Details : USFDA approved generic version of Sevelamer Carbonate which is used to manage elevated levels of phosphate in the blood of patients with chronic kidney disease.
Brand Name : Renvela-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 10, 2024
Lead Product(s) : Fluoxetine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Pharma Gets USFDA Nod for Antidepressant Medication
Details : Fluoxetine hydrochloride (Prozac) is an SSRI antidepressant used for major depressive disorder, OCD, bulimia, and panic disorder.
Brand Name : Prozac-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 08, 2024
Lead Product(s) : Gabapentin
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Gabapentin Tablets USP, 600 mg and 800 mg
Details : USFDA approved generic version of Gabapentin tablet, which is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain.
Brand Name : Neurontin-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 05, 2024
Lead Product(s) : Pregabalin
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Pregabalin Capsules
Details : USFDA approved generic version of Pregabalin treatment of fibromyalgia. It binds to the alpha2-delta subunit which is involved in anti-nociceptive and antiseizure effects.
Brand Name : Lyrica-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 25, 2024
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Launches Icosapent Ethyl Acid Soft Gel Capsules in Partnership with Amneal
Details : Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Brand Name : Vascepa-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 02, 2023
Lead Product(s) : Levetiracetam
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Levetiracetam Oral Solution
Details : USFDA approved generic version of Levetiracetam for the treatment of seizures. It prevents seizure activity via the selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.
Brand Name : Keppra-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 21, 2023
Lead Product(s) : Efavirenz,Emtricitabine,Tenofovir Disproxil Fumurate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Efavirenz/ Emtricitabine/tenofovir disoproxil fumarate) tablets a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, for the treatment of HIV-1 infection.
Brand Name : Atripla-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 04, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABACAVIR SULFATE
Dosage Strength : EQ 300MG BASE
Approval Date : 2016-10-28
Application Number : 91050
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 25MG
Approval Date : 2011-07-27
Application Number : 90912
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 50MG
Approval Date : 2011-07-27
Application Number : 90912
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 100MG
Approval Date : 2011-07-27
Application Number : 90912
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 2003-08-27
Application Number : 40511
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 2020-09-21
Application Number : 203647
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AB
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG;30MG
Approval Date : 2020-07-08
Application Number : 204649
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : SOLUTION; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 120MG/5ML;12MG/5ML
Approval Date : 1982-01-01
Application Number : 86366
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;30MG
Approval Date : 1988-09-30
Application Number : 89805
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : ACETAMINOPHEN AND CODEIN...
Dosage Strength : 300MG;60MG
Approval Date : 1988-09-30
Application Number : 89828
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KEY PRODUCTS
TOP RANKED SUPPLIER FOR:
FDA
District Decision : No Action Indicated
Inspection End Date : 2022-08-08
City : Singapore
State :
Country/Area : SG
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2022-08-08
District Decision : No Action Indicated
Inspection End Date : 2019-08-23
City : Chestnut Ridge
State :
Country/Area : US
Zip :
District :
Center :
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2019-08-23
District Decision : Voluntary Action Indicated
Inspection End Date : 2020-01-17
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2020-01-17
District Decision : No Action Indicated
Inspection End Date : 2020-03-05
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2020-03-05
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-02-08
City : Chestnut Ridge
State :
Country/Area : US
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-02-08
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-12-09
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2022-12-09
District Decision : Voluntary Action Indicated
Inspection End Date : 2023-02-24
City : Puducherry
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2023-02-24
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-16
City : Chestnut Ridge
State :
Country/Area : US
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-26
City : Bangalore
State :
Country/Area : IN
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-26
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-05-15
City : Milano
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-05-15
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EDQM
Type : GMP Certificates based on a Distant Assessment
Number : OGY
EudraGMDP Key : 130922
Country : India
Issue Date : 2021-06-24
Post Code :
NCA Ref : IN-M-STRI
City : Periyakalapet
Type : GMP Certificates
Number : UK GMP 2000...
EudraGMDP Key : 100011
Country : India
Issue Date : 2020-08-18
Post Code :
NCA Ref : 117007-STRID...
City : PERIYAKALAPET
Type : GMP Certificates
Number : NL/H 19/201...
EudraGMDP Key : 55747
Country : India
Issue Date : 2019-08-12
Post Code :
NCA Ref : 12922-STRIDE...
City : BANGALORE
Type : GMP Certificates
Number : UK MIA 1360...
EudraGMDP Key : 46723
Country : United Kingdom
Issue Date : 2018-02-22
Post Code :
NCA Ref : 4119-STRIDES...
City : WATFORD
Type : GMP Certificates
Number : UK API 2000...
EudraGMDP Key : 41218
Country : India
Issue Date : 2017-04-25
Post Code :
NCA Ref : 14223367-STR...
City : CUDDALORE
Type : GMP Certificates
Number : UK API 2000...
EudraGMDP Key : 41657
Country : India
Issue Date : 2017-04-28
Post Code :
NCA Ref : 16179217-STR...
City : PERIYAKALAPET
Type : GMP Certificates
Number : UK API 2000...
EudraGMDP Key : 41658
Country : India
Issue Date : 2017-04-28
Post Code :
NCA Ref : 16179217-STR...
City : PERIYAKALAPET
Type : GMP Certificates
Number : UK GMP 2000...
EudraGMDP Key : 51814
Country : India
Issue Date : 2019-01-10
Post Code :
NCA Ref : 12922-STRIDE...
City : BANGALORE
Type : GMP Certificates
Number : UK GMP 2000...
EudraGMDP Key : 53295
Country : India
Issue Date : 2019-01-10
Post Code :
NCA Ref : 12922-STRIDE...
City : BANGALORE
Type : GMP Certificates
Number : UK GMP 2000...
EudraGMDP Key : 18963
Country : India
Issue Date : 2013-05-09
Post Code :
NCA Ref : 1275284-STRI...
City : BANGALORE
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
